Analytical Product Lead, Quality Control (Capitol Heights)

bluebird bio in Capitol Heights, MD

  • Industry: Healthcare - Allied Health - Medical Biller/Coder
  • Type: Full Time
  • $124,590.00 - 163,390.00
position filled

Analytical Product Lead, Quality Control

We seek an experienced Sr. Analyst/ Scientist to join our newly created Analytical Product Lead team within Quality Control. This individual will represent QC on the product CMC teams, own the QC-related sections of regulatory filings, and assure a harmonized approach across product types. The APL function will work with client groups within QC (Specifications, Stability, Method Validation, Operations) and interface with CMC teams, Product Teams, Quality Assurance, Supply Chain, Manufacturing, Process Development and other cross-functional teams.

About the Role:

  • Represent QC at Product CMC Team(s)
  • Horizontally Integrate with subject matter experts across QC functional areas (Labs, Operations, Methods, Validation, Specs, Batch Analysis, Stability, reference standard) and utilize information within these areas to keep CMC team informed
  • Respond to new CMC requests
  • Understand timelines, constraints, opportunities, and communicate issues, status, and timing changes that are CMC impacting
  • Single point of contact for Regulatory-CMC for authoring/updating clinical and commercial filings (IND, IMPD, BLA, MAA) and responding to agency questions
  • Facilitate QCs awareness of and track regulatory interactions, queries, commitments, and method introduction/change strategies
  • Help to maintain harmonization of approach across product teams (analytical sections style, level of detail)

About You:

  • BS, MS, or PhD in a Chemistry, Biochemistry, or other related field
  • 5-10+ years in analytical development or QC
  • Highly developed communication skills and emotional intelligence to build relationships within and across functions
  • Experience with scientific writing, US/EU regulatory expectations and CTD section authorship
  • Demonstrate a strong initiative and scientific leadership
  • Superb organizational, analytical, and communications skills and do-what-it-takes attitude
  • Self-directed individual who is able to work with limited direction in a fast-paced, goal-oriented environment
  • Willingness to embrace and demonstrate the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
Will you now or in the future require bluebird bio to commence (sponsor) an immigration case in order to employ you (for example, H-1B or other employment-based immigration case)? *

Point of Data Transfer - GDPR *

Thank you for your interest in applying for a role at bluebird bio, Inc., a U.S. based company with its headquarters at 60 Binney Street, Cambridge, Massachusetts, USA 02142, or one of our subsidiary companies (bluebird or we or us). Before you submit your application, please read this notice and consent form, which explains why we need the information included in your application and what we will do with it. If you are happy to proceed, please click the submit button below, which provides your consent to our processing your personal data in line with this notice.

What information do we ask you to provide?

The personal information (Your Information) we seek in the application form is used to help us assess your suitability for the roles for which you are applying and for various analytics to help us improve our recruiting process. The information includes:

Your name and contact information

Details of any previous qualifications and other information included within your resume and cover letter (if included)

Details of your previous salary if provided

Whether you have the right to work lawfully in the country where the position is situated - as this is a legal requirement any employer must satisfy

What happens to your application form and supporting data once you submit it?

The application form and the information you have included in it is held on a database that is stored on a secure cloud server system operated by a third-party vendor, currently Greenhouse Recruiting (Greenhouse). Your Information will also be entered into a database that is only accessible to bluebird and will be used to improve the recruiting and hiring experience for candidates. This includes analytics on the hiring process and future communications with candidates about potential jobs which may fit your experience or relevant content specific to bluebird.

Transfer of data outside Europe

Greenhouses servers are located in the US and therefore once you submit your application form, your personal information will be transferred outside the European Economic Area (EEA), even if you are applying for a European position. Further, your information will be made available to other companies in the bluebird group with open positions for which you have applied. We not only seek your consent to this transfer, but we also have in place a Data Transfer Agreement, (based on so-called EU model clauses), between each of our European companies and bluebird bio, Inc., in the US. The Agreement provides for any data transferred outside the EEA to be processed in compliance with EU data protection rules.

Your rights in relation to Your Information

You have the right to access, correct and erase Your Information at any time. If you want to exercise these rights, or have any questions relating to the processing of Your Information, you can contact bluebird at ...@bluebirdbio.com. In addition, you have the right to complain to the data protection authority in your country if you consider that bluebird bio has infringed your privacy rights.

Security measures

The Greenhouse database has security features built into it and Greenhouse regularly tests these and has data recovery systems in place in the unlikely event of a crash. Greenhouse personnel are not given access to your personal data. Only authorised personnel within the hiring, recruitment, HR or legal teams at bluebird can access the system. Their entry to the system is through individually-issued passwords. Further information about the security features of our recruitment process can be obtained by emailing ...@bluebirdbio.com.

Consent

If having read this notice you consent to our processing your personal data in the manner set out above, please click on the Apply Now button below. Even having done so, you may decide to withdraw your consent at any time by contacting ...@bluebirdbio.com. If you opt to do that, we will cease to process your application and the application will be deleted from the database.

Agreed

U.S. Equal Opportunity Employment Information (Completion is voluntary)

Individuals seeking employment at bluebird bio are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

Gender Are you Hispanic/Latino? Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Veteran Status

Form CC-305

OMB Control Number 1250-0005

Expires 1/31/2020

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

Because we do business with the government, we must reach out to, hire, and provide equal opportunity to qualified people with disabilities 1 . To help us measure how well we are doing, we are asking you to tell us if you have a disability or if you ever had a disability. Completing this form is voluntary, but we hope that you will choose to fill it out. If you are applying for a job, any answer you give will be kept private and will not be used against you in any way.

If you already work for us, your answer will not be used against you in any way. Because a person may become disabled at any time, we are required to ask all of our employees to update their information every five years. You may voluntarily self-identify as having a disability on this form without fear of any punishment because you did not identify as having a disability earlier.

How do I know if I have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Blindness
  • Deafness
  • Cancer
  • Diabetes
  • Epilepsy
  • Autism
  • Cerebral palsy
  • HIV/AIDS
  • Schizophrenia
  • Muscular dystrophy
  • Bipolar disorder
  • Major depression
  • Multiple sclerosis (MS)
  • Missing limbs or partially missing limbs
  • Post-traumatic stress disorder (PTSD)
  • Obsessive compulsive disorder
  • Impairments requiring the use of a wheelchair
  • Intellectual disability (previously called mental retardation)
Disability Status Reasonable Accommodation Notice

Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

1 Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp .

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.


Associated topics: bill, biller, collection, data, front, hospital transcriptionist, medical biller, number, receivable, transcription medical

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